A study published in the Journal of Oncology Practice examining the effects of new mandates implemented by large national healthcare insurance payers (LNHPs) requiring consultation with a geneticist or genetic counselor have restricted access to necessary BRCA1/2 testing.

The nationwide research showed that when LNHPs instituted pre-testing consultation policies, test cancellation rates increased from 13.3% to 42.1% for at-risk patients whose cancer-related specialists had ordered exams. Cancellations for African American and Latino patients were even higher at 48.9% and 49.6% respectively.

“A critical shortage of genetic counselors and medical geneticists means that often patients must endure extremely lengthy waiting periods for a pre-testing appointment. Also, they may not have access to these professionals locally,” said Sheldon Feldman, M.D., chief of breast surgery division of New York-Presbyterian Hospital/Columbia University Medical Center.

The policies requiring a genetic consultation before being cleared to receive a test have been gaining traction among LNHPs in the past few years, as the tests have become more popular, in what many have seen as a broad-brush attempt to eliminate inappropriate and unneeded testing. But these policies have likely swept up a large cohort of patients who could significantly benefit from them. To whit, the new study found that most cancellations were for patients who met testing criteria and would potentially benefit from the knowing the results.

Numerous professional associations and societies including the American Society of Clinical Oncology, American College of Medical Genetics and Genomics, and American College of Surgeons/National Accreditation Program for Breast Centers have opposed these changes in payers’ policies.

“This policy is extremely detrimental to patient care, and the difficulties are easily rectified,” said Dr. Feldman, who is also president of the American Society of Breast Surgeons. “Numerous physician specialists have specific training that qualifies them to evaluate, counsel and appropriately order tests for at-risk patients, helping to streamline and broaden testing access for those who qualify. Many related specialists have been providing these services since the mid-1990s, and genetic consultations not only compromise patient care but also impose new limits on the scope of these physicians’ practices.”

To conduct the study, researchers focused on patients covered by a large insurance payer that recently adopted a genetic specialist evaluation policy. Using a commercial lab BRCA testing database, the study looked at the number of tests ordered that did not result in a final report to determine test cancellation rates. This data was gathered for a 12-month period prior to and following adoption of the policy, with a four-month hiatus to compensate for policy adoption.

The reasons for test cancellation were tracked using a variety of measures. Missing insurance information, typically due to failure to meet with a genetic counselor to complete the data, emerged as the primary cause. “Notably, the mutation positive rate in the pre- and post-mandatory counseling remained similar, suggesting that patients were not being inappropriately referred,” said Pat Whitworth, M.D., director of the Nashville Breast Center and lead author of the study.

The study’s control group comprised patients covered by insurance companies that did not require genetic consultation prior to receiving BRCA testing. Examined over the same time period, the control group’s test cancellation rates remained low and showed little change over the study period.

“In an era when precision medicine strategies are evolving daily, misallocation of [genetic counseling] services and implementation of policies that require [genetic counseling] approval for all hereditary cancer genetic testing serve not only as barriers to care for patients today, but as barriers to the advancement of the state of the art of cancer treatment tomorrow,” the study authors concluded.